~ Study Results Position Femara® as the Only Aromatase Inhibitor to Show a Survival Advantage over Tamoxifen in a Well-Controlled Phase III Study ~
DORVAL, Quebec (December 10, 2001) -- New data from a Phase III study demonstrate that Femara® (letrozole) may improve survival of postmenopausal women with locally advanced or metastatic breast cancer who are appropriate for hormone therapy, when compared to tamoxifen. The data, stemming from the largest single study ever to evaluate a hormonal therapy in advanced breast cancer, were announced today at the San Antonio Breast Cancer Conference, San Antonio, Texas in the United States.
"Demonstrating a survival advantage with continuous quality of life has been, and still is a critical issue for oncologists when evaluating the most appropriate therapy for patients with metastatic cancer. Specifically for breast cancer, the number of therapies that have proven a survival advantage remains limited," said Dr. Denis Soulières, Medical Oncoligist and coordinator of clinical research in oncology at Hôpital Notre-Dame du CHUM in Montreal. "There is now new data on hormonal therapy for postmenopausal metastatic breast cancer patients demonstrating that an aromatase inhibitor, Femara®, is superior to tamoxifen in stopping disease progression and (preventing early death from cancer) possibly prolonging life. This data is compelling enough to warrant the use of Femara® preferentially over tamoxifen in first line for postmenopausal patients with metastatic breast cancer starting an hormonal therapy."
DATA SHOW Femara® IMPROVES SURVIVAL AND PROLONGS TIME TO DISEASE PROGRESSION
The randomised, double-blind study of 907 postmenopausal women (453 on Femara®; 454 on tamoxifen) was designed to compare Femara® versus tamoxifen as first-line therapy in women with locally advanced or metastatic breast cancer. Survival rates at one and two years show Femara® to have a statistically significant survival advantage compared to tamoxifen (p=0.02).
The data also demonstrated that since initiation of the study (November, 1996), approximately five years ago, more women who had begun their therapy on Femara® were still alive and free of tumour progression compared to those started on tamoxifen (48 vs. 27, p=0.011). In addition, patients taking Femara® had a 78 per cent (p=0.0002) greater chance of responding to treatment than patients treated with tamoxifen, and the chance that their tumours would progress was 30 per cent less with Femara® than with tamoxifen (p=0.0001). This updated analysis also confirms the primary analysis (Spring, 2000) demonstrating that Femara® significantly delays progression of disease for a median 9.4 months, as compared to a median 6.0 months for tamoxifen (p=0.0001).
Femara® HELPS MAINTAIN PERFORMANCE
As breast cancer advances, it affects a woman's ability to function and perform routine daily activities. Researchers measured the ability of women in the study to complete routine daily activities by using the Karnofsky Performance Score - a standard clinical measurement tool based on a 100 point performance scale (100 being the top performance point) and where a change of 20 points or more is considered clinically relevant. These results showed that, on average, women taking Femara® were able to maintain the level of functioning they experienced when entering the study for a longer period of time than those women taking tamoxifen. The median time that women taking Femara® could more closely maintain the level of functioning they had at study entry (<20 point drop) was longer than 4.6 years, while in women taking tamoxifen the median time to experience a significant decrease in performance (>20 point drop) was 3.5 years.
"The Femara® data marks the first time an hormonal therapy has demonstrated a clear two-year survival advantage over tamoxifen for advanced breast cancer patients," said Jean-Francois Pouliot, PhD, Medical Expert, Novartis Oncology. "Novartis is very excited to be able to clearly demonstrate the benefits of Femara® in terms that make a practical difference to healthcare professionals and - most importantly - to patients and their families."
IMPACT OF BREAST CANCER
This year, the Canadian Cancer Society estimates 19,500 new cases of breast cancer will be diagnosed - approximately half of which will already be in an advanced stage when detected. For women, breast cancer is second only to lung cancer as a leading cause of death due to cancer. In 2001, it is estimated that there will be 5,500 deaths due to breast cancer.
ABOUT Femara®
Femara®, an aromatase inhibitor, is an oral once-a-day first-line treatment for postmenopausal women with advanced breast cancer. Femara® is currently available in more than 75 countries worldwide, with first-line approval already gained in more than 50 countries, including Canada. Femara® is also approved as neo-adjuvant (pre-operative) therapy in 20 countries around the world.
FORWARD LOOKING STATEMENT
This release contains certain "forward-looking statements" relating to the Company's business, which can be identified by the use of forward-looking terminology such as "demonstrate," "may survive," "strongly suggest," or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of Femara®. Such statements reflect the current views of the Company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of Femara® or the Company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Some of these are uncertainties relating to unexpected regulatory delays, government regulation or competition in general, as well as factors discussed in the Company's Form 20F filed with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialise, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.
NOVARTIS PHARMACEUTICALS CANADA INC.
Novartis (NYSE: NVS) is a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 2000, the Group's ongoing businesses achieved sales of $25.5 billion and a net income of $5.7 billion. The Group invested approximately $3.5 billion in R&D. Headquartered in Basel, Switzerland, Novartis employs about 70,000 people and operates in over 140 countries around the world.
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